ph-0151
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Zoladex® (goserelin acetate)

Policy Number: PH-0151

Subcutaneous

Last Review Date: 04/04/2022

Date of Origin: 11/28/2011

Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

 

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization
  • Endometriosis: Coverage will be provided for 6 months and is NOT eligible for renewal.
  • Endometrial Thinning: Coverage will be provided for 2 doses only (given 4 weeks apart) and is NOT eligible for renewal.
  • All other indications: Coverage will be provided for 12 months and may be renewed.
  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • 3.6mg injection – 1 injection every 28 days
  • 10.8mg injection – 1 injection every 12 weeks (Prostate and Breast Cancer only)

B. Max Units (per dose and over time) [HCPCS Unit]:

  • Prostate & Breast Cancer – 3 billable units every 84 days
  • All Other Indications – 1 billable unit every 28 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1,2

  • Females of reproductive potential have a negative pregnancy test prior to start of therapy and will use an effective method of nonhormonal contraception during treatment and for 12 weeks after treatment (Note: This excludes use in patients receiving palliative treatment of advanced breast cancer); AND

Breast Cancer † 2,3

  • Patient is a pre- or peri-menopausal woman or a male with suppression of testicular steroidogenesis; AND
  • Patient’s disease is hormone receptor-positive; AND
    • Used in combination with adjuvant endocrine therapy; OR
    • Used in combination with endocrine therapy for recurrent unresectable or metastatic disease; OR
    • Used as palliative treatment for advanced disease

Prostate Cancer † 1-3

Dysfunctional Uterine Bleeding (Endometrial Thinning) † 2

  • Used prior to endometrial ablation

Endometriosis † 2

  • Patient has not received prior-treatment with a gonadotropin releasing hormone (GnRH) agonist for this indication within a 6-month prior period

FDA Approved Indication(s), Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug.  Examples of unacceptable toxicity include: severe QT/QTc interval prolongation, severe hyperglycemia and diabetes, cardiovascular toxicity (e.g., myocardial infarction, stroke, etc.), hypercalcemia, severe injection site injury, tumor flare phenomenon, severe hypersensitivity reactions, etc.; AND

Prostate Cancer/Breast Cancer

  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

Endometriosis/ Dysfunctional Uterine Bleeding (Endometrial Thinning)

  • May not be renewed
  1. Dosage/Administration 1,4

Indication

Dose

Breast cancer

Administer 3.6 mg depot every 4 weeks

OR

Administer 10.8 mg depot every 12 weeks

Dysfunctional Uterine Bleeding (Endometrial Thinning)

(3.6 mg only) Administer 3.6 mg for 1 or 2 doses with each depot given 28 days apart.

  • When 1 depot is given, endometrial ablation surgery should be performed at 4 weeks. If 2 depots are given, surgery should be performed within 2-4 weeks following the second depot dosage.

Endometriosis

(3.6 mg only) Administer 3.6 mg depot every 28 days for 6 months

Prostate Cancer

Stage B2-C Prostatic Carcinoma

  • Administer 3.6 mg depot 8 weeks before radiotherapy, followed in 28 days by 10.8 mg depot. Alternatively, four injections of 3.6 mg depot can be administered at 28-day intervals, two depots prior to and two during radiotherapy.

Palliative Treatment of Advanced Prostate Cancer

  • Administer 3.6 mg depot every 4 weeks

OR

  • Administer 10.8 mg depot every 12 weeks
  1. Billing Code/Availability Information

HCPCS Code:

  • J9202 – Goserelin acetate implant, per 3.6 mg: 1 billable unit = 3.6 mg

NDC:

  • Zoladex 10.8mg 3-Month Implant: 70720-0951-XX           
  • Zoladex 3.6mg Implant: 70720-0950-XX    
  1. References
  1. Zoladex 10.8mg [package insert]. Deerfield, IL; TerSera Therapeutics LLC; December 2020.  Accessed February 2022.
  2. Zoladex 3.6mg [package insert]. Deerfield, IL; TerSera Therapeutics LLC; December 2020. Accessed February 2022.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for goserelin acetate National Comprehensive Cancer Network, 2022.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2022.
  4. Noguchi S, Kim HJ, Jesena A, et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer. 2016; 23(5): 771–779.  Published online 2015 Sep 9.  doi: 10.1007/s12282-015-0637-4
  5. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A57655). Centers for Medicare & Medicaid Services, Inc. Updated on 11/21/2019 with effective date 10/03/2018. Accessed March 2022.
  6. National Government Services, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453). Centers for Medicare & Medicaid Services, Inc. Updated on 12/22/2021 with effective date 01/01/2022. Accessed March 2022.
  7. Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776). Centers for Medicare & Medicaid Services, Inc. Updated on 10/08/2021 with effective date 10/01/2021. Accessed March 2022.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C50.011

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C61

Malignant neoplasm of prostate

N80.0

Endometriosis of uterus

N80.1

Endometriosis of ovary

N80.2

Endometriosis of fallopian tube

N80.3

Endometriosis of pelvic peritoneum

N80.4

Endometriosis of rectovaginal septum and vagina

N80.5

Endometriosis of intestine

N80.6

Endometriosis in cutaneous scar

N80.8

Other endometriosis

N80.9

Endometriosis, unspecified

N92.4

Excessive bleeding in the premenopausal period

N92.5

Other specified irregular menstruation

N93.8

Other specified abnormal uterine and vaginal bleeding

Z85.46

Personal history of malignant neoplasm of prostate

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s):  N

NCD/LCD Document (s): A57655

 

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57655&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s):  L, H

NCD/LCD Document (s): A56776

 

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56776&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

 

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52453&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

ZOLADEX® (goserelin acetate) Prior Auth Criteria
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